The healthcare market is evolving with consumers increasingly open to the use of probiotic products to manage not only digestive health, but also to promote the general well-being of the body.
Demonstrating this, based on trends and market data, the global probiotics industry is expected to reach a value of USD 75.9 billion by 2027 (market size was estimated at USD 54.21 billion in 2020).
Reflecting this trend, market surveys have observed a rapid increase in the number of new product launches in recent years. Furthermore, data reveal that two out of five consumers say they are interested in using probiotics as a functional ingredient.
The therapeutic application targets of products with probiotics are numerous and go beyond the already well-known and established use of this component for gut and skin health. Emerging applications include claims related to bone and joint health, the oral cavity, and their application in pregnancy and lactation, to name but a few. But the areas that have seen the most growth in recent years are related to the mental sphere and, in particular, relate to improving sleep, mood and cognitive functions. In fact, 19% of consumers think that the main benefit to be gained from consuming probiotics is related to mental wellbeing and mood, while 25% think that this component can be useful for increasing the quality of rest.
Probiotic products are therefore now one of the main allies of consumers looking for new innovative solutions to promote and preserve the body's general wellbeing and combat various health problems.
Source: Innova Market Insights, "What’s Next in Probiotic Supplements? Global with a Focus on Asia Pacific"
Biofarma Group is a probiotic products manufacturer that develops and manufactures solutions released on the market as food supplements or medicines, with applications in numerous therapeutic areas such as immune and gastrointestinal system health, heart health, women's wellbeing, mental wellbeing, metabolic system, active ageing, uro-genital health, sun care and nutricosmetics.
To manufacture these products, Biofarma Group can rely on two state-of-the-art production facilities located in Italy and the United States.
The first, located in Mereto di Tomba, the Group's headquarters, comprises an area entirely dedicated to the manufacture of probiotic products. Part of this area consists of the pharmaceutical workshop, which is a tower-like structure comprising a total of 15 processing rooms spread over 3 floors, with rigorous and strictly controlled environmental conditions to ensure the production of products with probiotics of the highest quality standards.
The facility was the first in Europe to obtain AIFA certification for the production and packaging, in the same environment and facilities, of probiotic-based OTC drugs and food supplements, for the global market.
The department is built according to the most stringent GMP (Good Manufacturing Practices) criteria, i.e. global standards that help companies improve their production processes while maintaining a high standard of product quality and safety. The reason behind their creation is to globally guarantee the production of items of primary importance to humans, such as drugs and food, with the lowest possible health risk.
These areas are equipped with filtration and air dehumidification systems to create temperature and humidity-controlled environments. The filtration system guarantees an ISO 8 level of air quality, a standard that certifies the level of quality and cleanliness of the air inside the rooms where production takes place, verified according to microbiological parameters and the quantity of particles in the atmosphere during processing.
The area has been constructed with panels made of pharmaceutical material, the junctions between walls and walls/floor have shells to eliminate areas of dust accumulation.
For the same purpose, the ceilings are lowered by false ceilings, the light fixtures are fluorescent and protected, and the air diffusers and the air shots are coplanar, all in order to minimise the risk of dust accumulation and facilitate cleaning.
The facility is divided into rooms, each of which is dedicated to a specific production line.
Access to the rooms is exclusively through a material bushing and a personnel bushing, which are realised through two mutually locking doors; both are overpressure in relation to the production area.
In addition, the preparation of raw materials for mixing activities is carried out under laminar flow hoods, which help to ensure the cleanliness and thus the quality and safety of the finished products.
Within the facility, Biofarma manufactures probiotic products, exclusively in the form of capsules, tablets, powders and the innovative food supplement Oildrop, a special product for children, consisting of a formulation and technology that allows the solid component of the product to be adequately divided with the liquid component (oil).
Finally, the finished products manufactured in the pharmaceutical workshop are packaged in stick packs, blister packs or Active-Vial, depending on the galenic form.
The probiotic production area of the Mereto plant is not limited to this structure; rather, it includes other areas within the plant that are also constructed with pharmaceutical finishes and consist of clean rooms classified according to GMP and ISO8 standards. The production lines located in this area are used for the production of tablets, capsules, powders and liquids.
Among the different types of packaging produced in these areas, we find innovative technologies such as:
the T-Win, a sachet consisting of two different chambers that allows the packaging of distinct but miscible powders, to be kept separate until consumption;
the Dry Cap, a special two-stage packaging technology that allows the solid part of the product (powder) and the liquid part to be enclosed and at the same time separated in the same main pack.
The US facility of Biofarma Group, located in North Brunswick, New Jersey, also includes an area dedicated to the probiotic production, with a current annual capacity of more than one billion finished doses.
The plant's high quality and safety standards are proven and guaranteed by the various certifications obtained: ISO-8 certification, NSF (food safety certification), UL (Underwriters Laboratories Inc. - for health safety), and US Pharmacopeia GMP certifications.
This is an independent area with strictly controlled temperature, humidity and airflow conditions to best guarantee the survival and stability of a wide range of probiotic strains.
Specifically, the basic temperature is maintained at 68 degrees Fahrenheit (+/-4°F) and humidity at 25% (+10/-0). However, the area is divided into mini-zones, each of which has specific temperature and humidity conditions, adjusted according to the needs of the production line installed inside.
Conditions are maintained through technologies and equipment that prevent contamination from outside air and environment such as high-speed roll-up doors, steel walls and solid ceilings.
The facility also features a double cone mixer with drum loading and a nitrogen filter, for mixing the raw materials needed to make the finished products.
In this area, supplements with probiotics are manufactured in uncoated tablets, capsules in different formats, powder products and custom specialty dosage forms; while the packaging forms provided are bottles, vials and blisters.
Innova Market Insights, "What’s Next in Probiotic Supplements? Global with a Focus on Asia Pacific", 2023
